Fluid Delivery System For Surgical Instruments

ABSTRACT

There is provided a penetratable toothed fastener for clamping tissue during surgery. The toothed fastener includes first and second legs each having longitudinal rows of transverse teeth and a securing member configured to pass through the transverse teeth to hold first and second legs closed relative to each other and about tissue. A locking mechanism is provided to retain the securing member within the first and second legs of the toothed fastener. The toothed fastener additionally includes receptacles for the receipt of medicant materials and holes in the teeth to dispense the materials to clamped tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority to U.S. Provisional patentapplication No. 61/049,820, the disclosure of which is herebyincorporated by reference herein.

BACKGROUND

1. Technical Field

The present disclosure relates to a fluid delivery system for surgicalinstruments. More particularly, the present disclosure relates to afastener for releasing treatment material to clamped tissue.

2. Background of Related Art

During certain surgical procedures as is often necessary to clamptissue, such as, vascular tissues, to prevent leakage therethroughduring surgeries. The procedure typically involves placing clips orclamps within an applicator device and applying the clamps to the tissueon one side of an area, for example a diseased section of vasculartissue or colonic tissue, and placing another set of clamps on theopposing side of the diseased section. Thereafter, the diseased sectioncan be excised and the resulting free ends of the tissue reattached.

During surgery certain problems may arise. For example, manipulation ofsurrounding tissue, as well as fluid pressure within the tissue, maycause loosening of the clamp and resulting leakage or even possibledetachment of the clamp. Additionally, it is often desirable to providecertain medicament or treatment materials such as, for example,biomechanical mediums or antimicrobials solutions to the tissues duringthe surgery.

Therefore, it is desirable to provide a mechanical fastening devicehaving a securing mechanism for maintaining the fastening devices in aclosed position during the surgery. It is further desirable to provide amechanical fastening device capable of applying medicament or treatmentmaterials to the tissues during the surgery.

SUMMARY

There is disclosed a toothed fastener for securing tissue. The toothedfastener generally includes an upper leg and a lower leg, each of theupper and lower legs having a row of teeth, each tooth having a proximalface and a distal face. The toothed fastener further includes alongitudinally extending securing member. A hole of predetermineddiameter is formed in each of the proximal and distal faces and is ofsufficient size to allow passage of the securing member therethrough.The upper or lower legs are movable from an open position to a closedposition s placing all the holes in longitudinal alignment such that thesecuring member can pass through all the holes in the teeth of the upperand lower legs.

In a specific embodiment, each tooth has a pair of spaced apart holesformed in each of the distal and proximal faces. In this embodiment, thesecuring member has first and second legs for passage through the pairof spaced apart holes. The securing member includes a backspan such thatthe first and second legs extend distally from the backspan.

In one embodiment, the hole formed in the distal face of the distal mosttooth is sized to engage the securing member in a friction fit fashion.

In a particular embodiment, each of the teeth are hollow or define areceptacle for receipt of material such that passage of the securingmember through the holes of the teeth releases the material into thespace between the first and second legs. The material may be containedwithin a puncturable capsule.

In the disclosed toothed fastener each leg has a base, each base havingan opening to the interior of the tooth for passage of material into thetooth. A membrane is provided covering the openings in each leg toretain the material within the teeth.

In one embodiment, a connector is affixed to a proximal end of each ofthe first and second legs. In a specific embodiment, the connector is aliving hinge. In a more specific embodiment, the living hinge is formedintegrally with the proximal ends of the first and second legs.

There is also disclosed a system for applying a fastener to tissueincluding an applicator having a first and a second jaw and a toothedfastener positionable within the first and second jaws. The toothedfastener includes an upper leg and a lower leg, each of the upper andlower legs having a row of transverse, longitudinally extending teeth,each tooth having a proximal face and a distal face. The toothedfastener also includes a longitudinally extending securing member. Ahole of predetermined diameter is formed in each of the proximal anddistal faces and is of sufficient size to allow passage of the securingmember therethrough. The upper or lower legs are movable from an openposition spaced apart to a closed position substantially adjacent eachother placing all the holes in longitudinal alignment such that thesecuring member passes through all the holes in the teeth of the upperand lower legs. The first and second jaws of the applicator are operableto move the upper and lower legs between the open and closed positions.

In one embodiment of the system, each tooth has a pair of spaced apartholes formed in the proximal and distal faces and the securing member isa staple bar having a backspan and first and second legs extendingdistally from the backspan. The first and second legs being configuredto pass through the pairs of spaced apart holes to secure the upper andlower legs in the closed position.

The applicator further includes a pusher, engageable with the backspanof the staple bar, to drive the staple bar distally relative to thetoothed fastener.

The present disclosure contemplates a fluid delivery system having anactuating handle assembly, a pair of jaws operably connected to thehandle assembly, the pair of jaws each having teeth defining openings,and a puncturing member receivable in the openings of the teeth, theteeth defining at least one receptacle containing a fluid. In certainembodiments, the pair of jaws includes a first jaw and a second jawarranged for clamping onto tissue. The fluid may be a medicament, tissuesealant or tissue adhesive. The fluid may be disposed in a puncturablecapsule, the securing member having a tip for puncturing the puncturablecapsule.

The present disclosure contemplates a tissue fastener having a first legand a second leg pivotably connected to one another, the first leg andsecond leg each having teeth defining openings, and a securing memberreceivable in the openings of the teeth. A surgical instrument forapplying the tissue fastener to tissue includes a pair of jaws and ahandle assembly operably arranged to move the jaws between a closedposition for clamping tissue and an open position for releasing thetissue. The jaws of the instrument are arranged to receive the tissuefastener and securing member. The surgical instrument includes a pusherfor advancing the securing member through the openings in the teeth ofthe fastener. The teeth may define at least one receptacle containing afluid. The fluid may be a medicament, tissue sealant or tissue adhesive.

In a further aspect, a toothed fastener comprises an upper leg and alower leg, each of the upper and lower legs having a row of transverselongitudinally extending teeth, each tooth having a proximal face and adistal face; a longitudinally extending securing member; and a hole ofpredetermine diameter formed in each of the proximal and distal faces.The upper or lower legs are movable from an open position spaced apartto a closed position wherein all of the holes are in longitudinalalignment enabling the securing member to pass through the holes tomaintain the fastener in the closed position.

In certain embodiments, each of the teeth are hollow for receipt ofmaterial such that the material is released into spaces defined betweenthe upper and lower legs. The material may be contained within apuncturable capsule. Each of the upper and lower legs may have a base,each base having an opening to the interior of the tooth for passage ofmaterial into the tooth. In certain embodiments, a membrane covering theopenings in each leg to retain the material within the teeth.

DESCRIPTION OF THE DRAWINGS

Various embodiments of the presently disclosed toothed fastener aredisclosed herein with reference to the drawings, wherein:

FIG. 1 is a perspective view of one embodiment of a toothed fastener andapplicator instrument;

FIG. 2 is a perspective view of the toothed fastener of FIG. 1;

FIG. 3 is a perspective view of an alternative, two part toothedfastener;

FIG. 4 is a perspective view of the toothed fastener of FIG. 1 withparts separated;

FIG. 5 is a side sectional view taken along line 5-5 of FIG. 2;

FIG. 6 is an end sectional view taken along line 6-6 of FIG. 5;

FIG. 7 is a perspective view of the distal end of one leg of the toothedfastener of FIG. 1;

FIG. 8 is a perspective view of the toothed fastener of FIG. 1 in aninitial position on the applicator;

FIG. 9 is a perspective view similar to FIG. 8 during initial puncturingand securement;

FIG. 10 is a side sectional view taken along line 10-10 of FIG. 9;

FIG. 11 is a perspective view of the toothed fastener during finalpuncturing and securement; and

FIG. 12 is a side sectional taken along line 12-12 of FIG. 11.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed fluid delivery system will now bedescribed in detail with reference to the drawings wherein like numeralsdesignate identical or corresponding elements in each of the severalviews. As is common in the art, the term ‘proximal” refers to that partor component closer to the user or operator, i.e. surgeon or physician,while the term “distal” refers to that part or component further awayfrom the user.

Referring to FIG. 1 there is disclosed a toothed fastener for use in asurgical instrument 12. Surgical instrument 12 can be of the type foropen surgery or laparoscopic surgery. In the present disclosure,surgical instrument 12 generally includes a handle 14 having an elongatetubular member 16 extending distally from handle 14. The surgicalinstrument has an end effector at a distal end of the tubular member 16,including an upper jaw 18 and a fixed jaw 20 that are movable withrespect to one another. An actuator or trigger 22 is movably mounted onhandle 14 and is operable to drive a securing and puncturing mechanismof fastener 10 into position as described in detail herein below. Thehandle 14 has a clamping handle 15 for moving the upper and lower jaws18 and 20 to clamp tissue therebetween. Surgical instrument 12additionally includes a rotation collar 24, affixed to elongate tubularmember 16, to orient upper and lower jaws 18 and 20 during surgery.

Referring now to FIG. 2, fastener 10 generally includes an upper leg 26and a lower leg 28. In this embodiment, upper leg 26 and lower leg 28are connected by a flexible, living hinge 30. Living hinge 30 allowsupper leg 26 and lower leg 28 to move between an open positionsubstantially spaced apart to a closed position wherein upper leg 26 issubstantially adjacent to lower leg 28. Upper leg 26 generally includesa base 32 having a row of transverse teeth 34 extending lengthwise alongbase 32. The teeth 34 are hollow so as to define a receptacle in eachtooth. Upper leg 26 additionally includes a distal most tooth 36 (ordiffer slightly to incorporate a locking mechanism as described in moredetail herein below). Base 32 includes a plurality of base openings 38that communicate with a corresponding receptacle in a correspondingtooth, and distal most tooth 36. Openings 38 are provided to receivematerials to be dispensed to tissue as described in more detail hereinbelow.

Lower leg 28 also includes a base 40 having a row of transverse teeth42. The teeth 42 are also hollow so as to define a receptacle in eachtooth. Lower leg 28 also includes a distal most tooth 44 on base 40. Itshould be noted here in that, while the following specific descriptionsof configurations, features and/or components of legs 26 and 28 may begiven with respect to one of legs 26 and 28, legs 26 and 28 may have thesame or different configurations, features and components and areidentical in all respects. Teeth 42 of lower leg 28 each include adistal face 46 and proximal face 48. Similarly, distal most tooth 44includes a distal face 50 and a proximal face 52. Pairs of holes 54 areprovided through distal face 46 and proximal face 48 of hollow teeth 42.Living hinge 30 is also provided with a pair of holes 56 which aresimilar in size and spacing to holes 54. Additionally, in a particularembodiment, distal most tooth 44 has a pair of spaced apart holes 58 inproximal face 52. Distal face 50 of distal most tooth 44 as a pair ofspaced apart holes 60 which can differ from holes 54 and 58 in size andmay form part of a locking mechanism as described in more detail hereinbelow. In the alternative, holes 60 may be similar to holes 54 and 58and the pair of spaced apart holes in a distal face of distal most tooth36 in upper leg 26 may differ from the pairs of spaced apart holes inteeth 34 to form the disclosed locking mechanism.

Upper leg 26 may be provided with a longitudinally extending membrane 62which serves to cover base openings 38 and secure materials withinhollow teeth 34 and 36.

Referring for the moment to FIG. 3, there is disclosed an alternative,two-part toothed fastener 64 which is substantially identical to toothedfastener 10 except for the lack of a living hinge. Fastener 64 generallyincludes an upper leg 66 and a lower leg 68. Upper leg 66 includes abase 70 and a row of transverse, hollow teeth 72. Upper leg 66 alsoincludes a hollow distal most tooth 74. A membrane 76 is provided acrossbase 70 and functions similar to membrane 62 described hereinabove.Similarly, lower leg 68 includes a base 78 having rows of transverse,longitudinally extending hollow teeth 80 and a hollow distal most tooth82. Each of hollow teeth 80 includes a distal face 84 and a proximalface 86. Hollow distal most tooth 82 also includes a proximal face 88and a distal face 90. A pair of spaced apart, holes 92 are provided indistal faces 84 and proximal faces 86 of teeth 80. Likewise, proximalface 88 of distal most tooth 82 includes a pair of spaced apart holes94. In a specific embodiment, distal face 90 includes a pair of spacedapart distal holes 96 which differ in size from holes 94 and 92 andserve as a locking mechanism which functions similar to that which willbe described herein below with respect to toothed fastener 10. As shown,upper leg 66 includes a membrane 76. As noted hereinabove, descriptionsof the upper and lower legs of the various embodiments of the toothedfastener include similar components, such as the addition of a membraneto lower leg 68, except for variations in distal most tooth 74 anddistal most tooth 82. Additionally, the operation of toothed fastener64, with the exception of a living hinge, functions the same as thatdescribed with respect to toothed fastener 10 hereinbelow.

Referring now to FIG. 4, toothed fastener 10 also includes a securingmember 100 which serves several functions. Securing member 100 has abackspan 102 and a pair of legs 104 and 106 extending distally frombackspan 102. Legs 104 and 106 terminate in distal tips 108 and 110.Securing member 100 is provided to secure upper leg 26 and lower leg 28in the closed position. Specifically, in the closed position, holesprovided in teeth 34 and 36 of upper leg 26 are in direct longitudinalalignment with holes 54, 58 and 60 in lower leg 28. Thus, by drivingsecuring member 100, and specifically legs 104 and 106, distally throughholes 56 in backspan 30 and through holes 54, 58 and 60 in lower leg 28and the corresponding holes in upper leg 26, upper leg 26 is secured inthe closed position relative to lower leg 28. Additionally, as tips 108and 110, of legs 104 and 106, passed through the holes of the teeth asdescribed herein, tips 108 and 110 puncture capsules of material, suchas capsules 112 in upper leg 26 and capsules 114 (FIG. 4) in lower leg28, to release materials contained therein onto tissue captured betweenupper leg 26 and lower leg 28. Capsules 112 and 114 may contain avariety of materials for treatment or joining of tissue, such as, forexample, biomedical mediums, antimicrobial solutions, etc. Materialsdisclosed in WO 2006/044800, the disclosure of which is herebyincorporated by reference herein, may be used. Lower leg 28 is providedwith a membrane 116 to secure capsules 114 within hollow teeth 42 and44. Finally, tips 108 and 110, in conjunction with smaller diameterholes 60 in distal face 50 of distal most tooth 44, may act as a lockingmechanism to prevent staple bar 100 from “backing out of” upper leg 26and lower leg 28 as described below. The leg 104 and leg 106 may besized to functionally engage the interior surface of the fastener teethinside holes 60, or the leg 104 and/or leg 106 have a textured surfacefor engaging inside the holes 60, or both.

Referring now to FIGS. 5-7, the details of teeth 34 and 36 of upper leg26 will now be described. As noted hereinabove, upper leg 26 includes adistal face 118 of teeth 34 and proximal and distal faces, 120 and 122,respectively, of teeth 36. Teeth 34 include holes 124 which are similarin size to holes 54 in teeth 42 of lower leg 28. Similarly, distal mosttooth 36 includes a pair of spaced apart holes 126 formed in proximalface 120 which are also substantially the same as holes 54. Distal face122 of distal most tooth 36 includes a pair of spaced apart holes 128which, together with tips 108 and 110 of securing member 100, may form alocking mechanism to secure staple bar 102 within upper and lower legs26 and 28. Specifically, holes 124 and 126 may have a diameter d1 whichis greater than the diameter d2 of pair of holes 128 in distal face 122of distal most tooth 36. Diameter d1 of holes 124 and 126 are sized tobe greater than the diameter of legs 104 and 106 of staple bar 100 so asto allow materials released from capsules 112 and 114 into the spacebetween upper leg 26 and lower leg 28 in the closed position. Diameterd2 of pair of holes 128 may be sized so as to grasp tips 108 and 110 ofstaple bar 100 in friction fit fashion thereby locking staple bar 100 inposition within upper leg 26 and lower leg 28. The teeth of upper leg 26define receptacles for a fluid material. The lower leg 28 has teethdefining receptacles and holes that are similar to those discussedabove.

Referring now to FIGS. 1 and 8-12, the use of toothed fastener 10 inapplicator 12 will now be described. As shown in FIG. 1, toothedfastener 10 is attached to jaws 18 and 20 of applicator 12, such as, forexample, by a snap-fit. Once jaws 18 and 20 have been properlypositioned around tissue (not shown), clamp handle 15 can be actuated toinitially move the jaws to the closed position relative to one another.As best shown in FIG. 8, this brings upper leg 26 into close cooperativealignment with lower leg 28. In this position, teeth 34 of upper leg 36interengage or interdigitate with teeth 42 of lower leg 28. Dependingupon the longitudinal orientation of upper leg 26 relative to lower leg28 within upper jaw 18 and lower jaw 20, one of distal most tooth 36 ofupper leg 26 or distal most tooth 44 of lower leg 28 will become adistally most extending tooth of toothed fastener 10. It should be notedthat, depending upon which distal most tooth 36 or 44 becomes thedistally most extending tooth, that tooth may be provided with holes ofthe smaller diameter d2 in the distal face thereof to secure securingmember 100. Securing member 100 is in a proximal most position withinelongate tubular member 16. Applicator 12 is provided with a pusher 130positioned against backspan 102 of securing member 100.

Referring now to FIG. 9, as trigger 22 is actuated, pusher 130 urgessecuring member 100 distally within elongate tubular member 16. Assecuring member 100 moves distally, tips 108 and 110 of legs 104 and 106pass through holes 56 in living hinge 30. Referring specifically to FIG.10, as legs 104 and 106 (not shown) moves distally tips 108 and 110passed through holes 54 in teeth 42 of lower leg 28 and holes 124 ofteeth 34 of upper leg 26. As legs 104 and 106 pass through holes 54 and124, tips 108 and 110 of legs 104 and 106 penetrate or puncture capsules112 and 114 of material M thereby releasing material M into the spacesdefined between teeth 42 and 34. In this manner, toothed fastener 10 iscapable of delivering material M to tissues captured between upper leg26 and lower leg 28. Additionally, the passage of legs 104 and 106through holes 54 and 124 serve to secure upper leg 26 in the closedposition relative to lower leg 28.

Referring now to FIGS. 11 and 12 and initially with regard to FIG. 11,as pusher 130 advances securing member 100 completely through upper leg26 and lower leg 28, tips 110 and 108 passed through holes 128 in distalface 122 of distal most tooth 36. As noted hereinabove, holes 128 mayhave a diameter d2 which is sufficiently small to engage tips 110 and108 in friction fit fashion. In this manner, securing member 100 is“locked” into position within upper or lower legs 26 and 28,respectively, thereby preventing staple bar 100 from inadvertentlypulling out of upper and lower legs 26 and 28. Additionally, thefriction fit of tips 110 and 108 within holes 128 serves to seal holes128 against any leakage of material M therethrough.

Referring to FIG. 12 as leg 106 passes through holes 126 in proximalface 120, capsule 112 is punctured and material and is released. Asshown, when distal most tooth 44 of lower leg 28 is not the distallymost extending tooth of tooth fastener 10, holes 60 in distal face 50are of the same diameter as holes 54 in proximal face 52 to allowpassage of material M therethrough as capsule 114 is penetrated. Whenthe jaws of the surgical instrument are released from the tissue,through operation of the clamp handle 15, the toothed fastener issecured onto the tissue, as the securing member 100 is retained in theteeth of upper leg 26 and teeth of lower leg 28. Further, the materialhas been deployed to the tissue site.

It will be understood that various modifications may be made to theembodiments disclosed herein. For example, the teeth of the legs may beformed with a single hole in each of the proximal and distal faces forreceipt of a single bar therethrough. Further, the tips of the staplebar may be enlarged to engage the distal most hole in rivet fashion.Additionally, the holes of the teeth may be covered be a penetratablemembrane and the material provided as a fluid within the teeth.Therefore, the above description should not be construed as limiting,but merely as exemplifications of particular embodiments. Those skilledin the art will envision other modifications within the scope and spiritof the claims appended hereto.

1-20. (canceled)
 21. A surgical fastener comprising: a first toothedmember and a second toothed member, the first toothed member and thesecond toothed member each defining at least one tooth defining areceptacle; a securing member receivable through the first toothedmember and the second toothed member; and a fluid material disposed inthe receptacle of the at least one of the tooth of the first toothedmember and the second toothed member.
 22. The surgical fastener asrecited in claim 21, wherein each tooth has a pair of spaced apart holesformed in each of the distal and proximal faces.
 23. The surgicalfastener as recited in claim 22, wherein the securing member is a barhaving first and second legs for passage through the pair of spacedapart holes.
 24. The surgical fastener as recited in claim 23, whereinthe securing member includes a backspan and the first and second legsextend distally from the backspan.
 25. The surgical fastener as recitedin claim 21, wherein at least one of first toothed member and the secondtoothed member has a hole formed therein, the hole being sized to engagethe securing member in friction fit fashion.
 26. The surgical fasteneras recited in claim 21, wherein the material is contained within apuncturable capsule.
 27. The surgical fastener as recited in claim 21,further comprising a connector connecting the first toothed member tothe second toothed member at a first end.
 28. The surgical fastener asrecited in claim 27, wherein the connector is a living hinge is formedintegrally with proximal ends of the first toothed member and secondtoothed member.
 29. The surgical fastener as recited in claim 21,wherein the first toothed member has a plurality of teeth definingspaces therebetween, and the second toothed member has a plurality ofteeth configured to be disposed in at least some of the spaces betweenthe teeth of the first toothed member.
 30. A surgical instrument,comprising a first jaw, a second jaw, a pusher, and the surgicalfastener as recited in claim 21, the first toothed member beingsupported on the first jaw, the second toothed fastener being supportedon the second jaw, and the pusher being engageable with the securingmember to advance the securing member through the first toothed memberand the second toothed member.